Safety Advice
Contraindications: Hypersensitivity to Rabeprazole, Domperidone or substituted Benzimidazoles or any excipient used in the formulation. It is contraindicated in patients with hepatic and/or renal impairment, prolactin-releasing pituitary tumour (prolactinoma), in pregnancy and during breastfeeding. It should not be used when stimulation of the gastric motility could be harmful, like gastrointestinal haemorrhage, mechanical obstruction or perforation.
Special Warnings and Precautions for Use: Co-administration of Razo-D with Atazanavir, Ketoconazole, Erythromycin or other potent CYP3A4 inhibitors are not recommended. Patients with Severe Hepatic Dysfunction: Although no evidence of significant drug-related safety problems, caution should be exercised when treatment with Rabeprazole sodium is first initiated in patients with severe hepatic dysfunction.
Pediatrics: It is not recommended for use in children under 16 years of age, as there is no experience of its use in this group.
Geriatrics: No overall differences in safety or effectiveness were observed between elderly subjects and younger subjects in the clinical studies with Rabeprazole.
Use in specific populations: Pregnancy and Lactation: It is contraindicated during pregnancy and should not be used during breastfeeding.
Effects on Ability to Drive and Use Machines: Razo-D has no or negligible effect.
Adverse Reactions: In general, both drugs are well tolerated separately. Following adverse drug reactions may occur with this fixed drug combination: headache, abdominal pain, dizziness, peripheral edema, asthenia, skin rash, diarrhea, flatulence, constipation, dry mouth, hepatic enzyme increase. Rare reports of hepatic encephalopathy have been received in patients with underlying cirrhosis. Rare reports of thrombocytopenia, neutropenia, leukopenia, bullous or urticarial skin eruptions, acute systemic allergic reactions, hepatitis, jaundice, myalgia, arthralgia, acute kidney injury, increased prolactin levels, QTc prolongation (frequency not known), galactorrhea, gynecomastia and amenorrhea are seen.
GGI-CO-A1-AQS-300023273-WM-I23-0023
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Composition 
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